Evaluating the Efficacy and Safety of Co-administrated Rosuvastatin/Ezetimibe and Telmisartan/Amlodipine

Addpharma

Status and phase: Completed; Phase 3

Conditions: Hypertension; Hypercholesterolemia

Treatments: Drug: Ezetimibe/Rosuvastatin; Drug: Telmisartan/Amlodipine 80 Mg-5 Mg ORAL TABLET; Drug: Telmisartan

Study type: Interventional

Funder types: Industry

Identifiers

NCT04158076

ROZETELA RCT

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of co-administrated Rosuvastatin/Ezetimibe and Telmisartan/Amlodipine in patients with primary hypercholesterolemia and essential hypertension.

Full description

This trial is a phase 3 study to evaluate efficacy and safety of co-administrated Rosuvastatin/Ezetimibe and Telmisartan/Amlodipine in patients with primary hypercholesterolemia and essential hypertension.

In "Rosuvastatin/Ezetimibe+Telmisartan/Amlodipine" treatment group, 48 subjects will be assigned and the subjects administer "Rosuvastatin/Ezetimibe+Telmisartan/Amlodipine" for 8 weeks.

In "Rosuvastatin/Ezetimibe +Telmisartan " treatment group, 48 subjects will be assigned and the subjects administer "Rosuvastatin/Ezetimibe+Telmisartan" for 8 weeks.

In "Telmisartan/Amlodipine" treatment group, 48 subjects will be assigned and the subjects administer "Telmisartan/Amlodipine" for 8 weeks.

Enrollment: 131 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed informed consent
• Subjects with hypertension and hyperlipidemia

Exclusion criteria

• Patient with known or suspected secondary hypertension
• Other exclusions applied

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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131 participants in 3 patient groups

Co-administered of AD-2071 and AD-2073

Experimental group

Description:

48 subjects will be assigned and the subjects will be administered "AD-2071(Ezetimibe/Rosuvastatin) and AD-2073(Telmisartan/Amlodipine)" for 8 weeks.

Treatment:

Drug: Telmisartan/Amlodipine 80 Mg-5 Mg ORAL TABLET

Drug: Ezetimibe/Rosuvastatin

Co-administered of AD-2071 and AD-2072

Active Comparator group

Description:

48 subjects will be assigned and the subjects will be administered "AD-2071(Ezetimibe/Rosuvastatin) and AD-2072(Telmisartan)" for 8 weeks.

Treatment:

Drug: Telmisartan

Drug: Ezetimibe/Rosuvastatin

AD-2073

Active Comparator group

Description:

48 subjects will be assigned and the subjects will be administered "AD-2073(Telmisartan/Amlodipine)" for 8 weeks.

Treatment:

Drug: Telmisartan/Amlodipine 80 Mg-5 Mg ORAL TABLET